11 completed, 2 terminated, 2 withdrawn, 1 recruiting. 17 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 17 | Completed 11, Terminated 2, Withdrawn 2, Recruiting 1, Unknown 1 |
| Phase 2 | 6 | Completed 2, Terminated 2, Unknown 1, Withdrawn 1 |
Follow Adrenal Insufficiency: new trials by email Literature Review of Adrenal Insufficiency trials Research Report on Adrenal Insufficiency
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN) SBT101 Treatment - AMN, AMN Gene Mutation | Phase 1 / Phase 2 | Terminated | SwanBio Therapeutics, Inc. | 9 | 2022-11-17 | 2026-08-26 |
| Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy Sobetirome (NV1205) - X-Linked Adrenoleukodystrophy | Phase 1 / Phase 2 | Withdrawn | NeuroVia, Inc. | 2018-08-01 | 2019-03-07 | |
| Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation Thiotepa--single daily dose, Thiotepa--escalated dose - Bone Marrow Failure Syndrome, Thalassemia | Phase 1 / Phase 2 | Completed | University of Florida | 6 | 2018-06-15 | 2023-09-15 |
| A Study of Infacort® Versus Cortef® in Healthy Adult Male and Female Subjects Infacort®, Cortef® - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 51 | 2018-04-16 | 2026-09-14 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 After Intravenous Administration in Healthy Volunteers OP-101 - Healthy | Phase 1 | Completed | Orpheris, Inc. | 8 | 2018-03-30 | 2018-09-17 |
| A Study of Chronocort® Versus Cortef ® in Healthy Adult Male Subjects Chronocort®, Cortef® - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 25 | 2018-02-19 | 2026-09-14 |
| Bioavailability of Infacort When Administered Onto Food Compared to Direct Oral Administration Infacort - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 19 | 2017-05-22 | 2026-09-14 |
| A Pilot Study of Vitamin D in Boys With X-linked Adrenoleukodystrophy vitamin D3 - X-linked Adrenoleukodystrophy | Phase 1 | Completed | Stanford University | 21 | 2016-11-21 | 2022-06-09 |
| Autologous Hematopoietic Stem Cell Gene Therapy for Metachromatic Leukodystrophy and Adrenoleukodystrophy transduced CD34+ hematopoietic stem cell - Metachromatic Leukodystrophy, Adrenoleukodystrophy | Phase 1 / Phase 2 | Unknown | Shenzhen Second People's Hospital | 50 | 2015-01-01 | 2022-05-31 |
| UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells DUOC-01 - Adrenoleukodystrophy, Batten Disease | Phase 1 | Recruiting | Joanne Kurtzberg, MD | 40 | 2014-09-01 | 2026-09-03 |
| Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia Solu-Cortef, Cortef - Addison Disease, Adrenal Hyperplasia Congenital | Phase 1 / Phase 2 | Completed | Haukeland University Hospital | 8 | 2014-03-27 | 2024-06-07 |
| An Investigational Study of Hydrocortisone Hydrocortisone granules, Hydrocortisone Tablet, i.v. Hydrocortisone Injection - Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 14 | 2013-10-01 | 2026-10-02 |
| Human Placental-Derived Stem Cell Transplantation Human Placental Derived Stem Cell - Mucopolysaccharidosis I, Mucopolysaccharidosis VI | Phase 1 | Completed | New York Medical College | 43 | 2013-04-01 | 2022-10-25 |
| Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD) Sobetirome - X-Linked Adrenoleukodystrophy, Adrenomyeloneuropathy | Phase 1 | Withdrawn | Thomas S. Scanlan | 2013-04-01 | 2014-02-14 | |
| Phase I/II Pilot Study of Mixed Chimerism to Treat Inherited Metabolic Disorders hematopoietic stem cell infusion - Hurler Syndrome (MPS I), Hurler-Scheie Syndrome | Phase 1 / Phase 2 | Terminated | Talaris Therapeutics Inc. | 3 | 2011-04-01 | 2023-04-12 |
| A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations Chronocort - Adrenal Insufficiency, Congenital Adrenal Hyperplasia | Phase 1 | Completed | Neurocrine UK Limited | 28 | 2011-02-01 | 2026-09-14 |
| An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Hydrocortisone, Chronocort - Congenital Adrenal Hyperplasia, Adrenal Insufficiency | Phase 1 | Completed | Neurocrine UK Limited | 30 | 2010-03-01 | 2026-09-14 |
Adrenoleukodystrophy (10) · Leukodystrophy, Metachromatic (4) · Adrenal Hyperplasia, Congenital (3) · Leukodystrophy, Globoid Cell (3) · Mucopolysaccharidosis I (3) · Anemia, Diamond-Blackfan (2) · Brain Diseases, Metabolic, Inborn (2) · Demyelinating Diseases (2) · Metabolism, Inborn Errors (2) · Mucopolysaccharidosis II (2) · Neuronal Ceroid-Lipofuscinoses (2) · Niemann-Pick Diseases (2) · Sandhoff Disease (2) · Tay-Sachs Disease (2)
Adrenal Gland Diseases (17) · Endocrine System Diseases (17) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (13) · Genetic Diseases, Inborn (13) · Nutritional and Metabolic Diseases (13) · Metabolic Diseases (12) · Metabolism, Inborn Errors (11) · Brain Diseases (10) · Central Nervous System Diseases (10) · Genetic Diseases, X-Linked (10) · Intellectual Disability (10) · Nervous System Diseases (10) · Neurobehavioral Manifestations (10) · Neurologic Manifestations (10)
Hydrocortisone (5) · GC 1 compound (2) · Cholecalciferol (1) · Dexamethasone (1) · Stem Cell Transplantation (1) · Vitamin D (1) · hydrocortisone hemisuccinate (1)
Neurocrine UK Limited (6) · Haukeland University Hospital (1) · Joanne Kurtzberg, MD (1) · NeuroVia, Inc. (1) · New York Medical College (1) · Orpheris, Inc. (1) · Shenzhen Second People's Hospital (1) · Stanford University (1) · SwanBio Therapeutics, Inc. (1) · Talaris Therapeutics Inc. (1) · Thomas S. Scanlan (1) · University of Florida (1)
United States (8) · United Kingdom (5) · Argentina (1) · Australia (1) · Chile (1) · China (1) · Colombia (1) · France (1) · Netherlands (1) · Norway (1) · Russia (1) · Ukraine (1)
A Koch (2) · Girish Sharma (2) · Biljana Horn, MD (1) · David Koeller, MD (1) · GuangFu Chen, M.D.,Ph.D (1) · Hua Jiang, M.D,Ph.D (1) · Jiacai Zhuo (1) · Joanne Kurtzberg, MD (1) · John Henderson, MD (1) · Katerina Simunkova, MD, PhD (1) · Keith Van Haren, MD (1) · Mitchell S Cairo, MD (1) · Qizhou Lian, M.D.,Ph.D. (1) · Salvatore Febbraro (1)
PMID 11231629, PMID 11399225, PMID 19892975, PMID 23845948, PMID 23966770, PMID 37172949
K23NS087151 (1)